High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Bone Marrow Transplantation for Relapsed and Refractory Germ Cell Cancer: A Phase II Pilot Study

Fecha de inicio: 1 de febrero de 1993

DISEASE CHARACTERISTICS: Histologically confirmed, measurable germ cell cancer relapsed or refractory after frontline therapy with cisplatin and etoposide-containing chemotherapy Other chemotherapy-sensitive solid tumors eligible (as of 06/11/97) Possibility of residual mass representing benign teratoma must be excluded Elevated serum tumor markers only are acceptable if possibilities of false-positive serum tumor markers or sanctuary disease have been excluded Also eligible after two to four cycles of conventional dose salvage chemotherapy, regardless of response No CNS or bone marrow involvement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 2 months Hematopoietic: Platelet count at least 100,000/mm3 Neutrophil count at least 1,500/mm3 Hepatic: Bilirubin, alkaline phosphatase, SGOT, and SGPT less than 3 times upper limit of normal, unless due to disease Renal: Creatinine less than 1.5 times upper limit of normal Creatinine clearance at least 60 ml/min Cardiovascular: Ventricular ejection fraction at least 45% No uncontrolled or severe cardiovascular disease including recent myocardial infarction, congestive heart failure, angina, life-threatening arrhythmia, or hypertension Pulmonary: DLCO and spirometry greater than 50% of predicted Other: Not HIV positive No active peptic ulcer No uncontrolled diabetes mellitus No active infection No previous or concomitant malignancy other than curatively treated basal or squamous cell carcinoma of the skin Not HBsAG positive PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior high-dose carboplatin, etoposide, or cyclophosphamide Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified